Measuring and testing – Sampler – sample handling – etc. – Withdrawing through conduit or receptacle wall
Patent
1997-10-03
2000-07-11
Raevis, Robert
Measuring and testing
Sampler, sample handling, etc.
Withdrawing through conduit or receptacle wall
G01N 100
Patent
active
060856025
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a new sampling device which makes it possible to carry out sterile removal of cell culture samples and other liquid media from bioreactors or sterile containers, protection from recontamination being provided by means of a sterile-filtered inert gas current.
The optimising of biotechnologically relevant production methods depends primarily on progress in the field of bioprocessing analysis, since this can provide findings which may lead to improved process control. Increasingly, modern methods of analysis such as cytofluorometry, high pressure liquid chromatography and biosensors are used for this. The prerequisite for this is the use of suitable sampling systems which constitute the link with the contents of the fermenter.
In the cultivation of animal, bacterial and plant cells, the aseptic method of operation and the sterile equipment used in the fermentation are of particular importance, since samples have to be taken continuously throughout the fermentation process in order to determine important parameters such as the growth characterisitics of the culture, the magnitudes relating to cell status and metabolic values.
The actual sampling from the bioreactor constitutes a critical operation, since it breaks through the sterile barrier to the contents of the fermenter. Therefore, in the case of fermentations lasting several weeks or in the event of a high sampling frequency, simple and reliable sampling methods are of great importance to the success of the process.
Moreover, sampling must give a true representation of the fermenter contents and must always be available, whilst the use of automated analytical systems increasingly demands the possibility of fully automated sampling.
The sampling devices used hitherto for this purpose are either provided by the manufacturers of bioreactors or are designs produced by the users themselves. These often improvised aids can only partly satisfy the abovementioned requirements or have the following specific disadvantages:
An important design feature is the manner of preventing back-contamination of the fermenter contents through the sampling route, since this constitutes the site of opening to the microbiologically contaminated environment.
This problem is solved in various ways: is used frequently, especially in bacterial fermentation. However, this method is complicated and not very reliable to operate, and also requires chemical or thermal disinfection of the piercing needle, e.g. by means of a flame. This method brings the risk of sample falsification, undesirable chemical attack and high-risk reattachment of the sample vessel. case, a sampling route is used only once and then abandoned. This method therefore requires dimensionally large constructions and frequent changing of the vessel arrangements, and also produces large amounts of material for disposal, e.g. syringes. requires pressuretight joints such as, for example, suitable tubing and considerable time spent on cooling, and is thus not suitable for laboratory reactors, in particular. particularly for the method of analysis known as FIA (Flow Injection Analysis). However, with this method, only cell-free sampling is possible.
Generally speaking, the above methods (apart from the FIA system) are unsuitable for automation owing to the need for manual operation and are thus not universally usable.
Commercially obtainable systems are described, for example, in Biotech-Forum 6, 274-288 (1989) and marketed by the firm Bioengineering, CH 8636 Wald.
The aim of the present invention is therefore to find a sampling system which satisfies the following minimum requirements: online analysis
According to the invention, the aim is achieved by the fact that, in the sampling device according to the invention, the point of separation from the microbiologically contaminated environment is constructed as a sterile defined protective gas current, which preferably consists of sterile air, according to the laminar air flow principle, in such a way that a laminar protective gas current (cf. fo
REFERENCES:
patent: 4669321 (1987-06-01), Meyer
patent: 5296197 (1994-03-01), Newberg et al.
patent: 5370146 (1994-12-01), King et al.
Noe Wolfgang
Schorn Peter
Voigt Hans
Devlin Mary-Ellen M.
Dr. Karl Thomae GmbH
Raevis Robert
Raymond Robert P.
Stempel Alan R.
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